RECRUITINGINTERVENTIONAL

Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels

Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With LDL-cholesterol Levels Above Recommended Targets for Reducing Cardiovascular Risk: Randomized Controlled Trial

About This Trial

The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol. The main questions it aims to answer are: * Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone? * Does lipodia help improve other health outcomes, like how confident participants feel in managing their health? Researchers will compare two groups: * Intervention group: Participants use the lipodia intervention and continue their usual treatment. * Control group: Participants continue with their usual treatment only. Participants will: * Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months * Have blood tests at each lab visit to check their cholesterol and other blood fat levels * Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)

Who May Be Eligible (Plain English)

Inclusion criteria - Age ≥ 18 - Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis - LDL-C levels above risk-adapted target - TG levels \< 400 mg/dL - Stability of potential drug treatment during the last 4 weeks - Stability of potential hormonal treatment during the last 6 months - Patient was made aware of lifestyle measures by GP or specialist - Consent to participation - Sufficient knowledge of the German language Exclusion criteria - Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes - Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes - Patients receiving plasmapheresis - Lp(a) \> 50 mg/dL - current pregnancy or planned pregnancy during the study period - planned major operations - liver dysfunction - end-stage renal failure - other systemic conditions that might interfere with successful study participation - Plans to change drug (including hormonal) treatment in the upcoming 6 months - Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion criteria * Age ≥ 18 * Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis * LDL-C levels above risk-adapted target * TG levels \< 400 mg/dL * Stability of potential drug treatment during the last 4 weeks * Stability of potential hormonal treatment during the last 6 months * Patient was made aware of lifestyle measures by GP or specialist * Consent to participation * Sufficient knowledge of the German language Exclusion criteria * Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes * Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes * Patients receiving plasmapheresis * Lp(a) \> 50 mg/dL * current pregnancy or planned pregnancy during the study period * planned major operations * liver dysfunction * end-stage renal failure * other systemic conditions that might interfere with successful study participation * Plans to change drug (including hormonal) treatment in the upcoming 6 months * Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past

Treatments Being Tested

BEHAVIORAL

lipodia

Participants will receive access to the digital health intervention lipodia in addition to TAU.

Locations (1)

GAIA AG

Hamburg, Germany